7 results
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7ms
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Sources: EU EUDAMED, US FDA
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Custom Made
FDA Enforcement
Class I
·Ongoing·Haimen Shengbang Laboratory Equipment Co. Ltd.·August 17, 2022
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1
FDA Enforcement
Class I
·Ongoing·Haimen Shengbang Laboratory Equipment Co. Ltd.·August 17, 2022
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type
FDA Enforcement
Class I
·Ongoing·Haimen Shengbang Laboratory Equipment Co. Ltd.·August 17, 2022
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
FDA Enforcement
Class I
·Ongoing·Centerline Biomedical Inc·May 28, 2025
StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing
FDA Enforcement
Class I
·Ongoing·Nova Biomedical Corporation·January 1, 2025
StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing
FDA Enforcement
Class I
·Ongoing·Nova Biomedical Corporation·January 1, 2025
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
FDA Enforcement
Class I
·Ongoing·Nova Biomedical Corporation·January 1, 2025